Prostate Cancer
Conditions
Keywords
prostate cancer, SBRT, stereotactic body radiotherapy, tumour boost
Brief summary
This is a single-arm feasibility study that is recruiting 40 patients with histologically-proven localized prostate cancer and MRI-defined lesion(s). Participants in this study will get MR-guided radiotherapy boost to MRI visible tumour before or after whole gland radiation. Participants will be followed-up as per standard of care schedule up to 5 years post-treatment.
Interventions
RADIATIONMR-guided Radiotherapy Boost
IMRT/VMAT prostate whole gland SBRT to 30 Gy in 5 fractions. MRL focal boost of 15 Gy in 1 fraction will be delivered either before or after whole gland SBRT.
Sponsors
University Health Network, Toronto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically-proven localized prostate cancer. * Low, Intermediate, and High-risk prostate cancer (ideally limited to 1 risk factor) * Low-risk: cT1-T2a, PSA \<10, and Gleason score 6 * Intermediate-risk: cT2b-c, PSA 10-20, and/or Gleason score 7 * High-risk limited to 1 risk factor: \>T2, PSA \>20, or Gleason score \>7 * Intra-prostatic tumour(s) demonstrated on mpMRI histologically confirmed limited to =/\< 1/3 total prostate volume * Planned for EBRT (+/- ADT) * ECOG 0 or 1 * 18 years of age or older * Ability to provide written informed consent to participate in the study
Exclusion criteria
* Prior radiotherapy to pelvis * Radiological evidence of regional or distant metastases at the discretion of the treating physician. * Active ulcerative colitis or Crohn's Disease, at discretion of treating physician * Ataxia Telangectasia and SLE * Contraindications to MRI; including patients with pacemakers/implantable cardiac defibrillator, cerebral aneurysm clips, shrapnel injury * Severe claustrophobia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of MR-guided Linear Acceleratorfor tumour-targeted intra-prostatic dose escalation as boost | Baseline | Total proportion of patients achieving predefined dosimetric parameters: PTV V100, PTV D90, Urethra V105, Rectum V75, Bladder V75 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acute Toxicity | Baseline to 5-year follow-up | Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| Late Toxicity | Baseline to 5-year follow-up | Late (more than 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 |
| Patient-reported quality-of-life assessed by EPIC-26 | Baseline to 5-year follow-up | Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (1-, 3-, and 6-months post radiation as well as years 1, 2, 3, 4, and 5) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26) |
Countries
Canada
Outcome results
None listed